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FDA Orders New Scrutiny for Medical Devices

Nov 19, 2013

Some widely available medical devices, though lifesaving for many patients, have never gone through the rigorous premarket approval process the U.S. Food and Drug Administration (FDA) routinely requires for new drugs. Researchers are concerned that devices like the external cardiac compressor may never be thoroughly evaluated by the agency and see this as a cause for concern.

Some of the products have been around in one form or another since before 1976, when the FDA started regulating devices, The New York Times reports. Devices presumed to be substantially equivalent to products already in use were cleared for sale without close scrutiny. The FDA designated such devices as high-risk devices, meaning they sustain human life, are instrumental in preventing harm, or pose an unreasonable risk to patients.

Congress has directed the FDA to put high-risk devices through rigorous testing or to change their classification. This worries consumer watchdog and patient safety groups because the FDA has proposed changing the classification of many of the products so they are no longer considered high-risk, or to vary their classifications depending on their use. Either of these changes would allow the products to continue to be sold without going through premarket approval, according to the Times.

Among high-risk devices to be “downgraded” are external pacemakers, access tubes implanted in blood vessels, a component of a lung device used for newborns, dental devices that are implanted near the brain, and screw systems used in spinal surgery, the Times reports. Defibrillators, metal-on-metal replacement hips, implanted pacemakers and female condoms will remain high-risk and must undergo premarket approval, the Times reports.

In a statement to the Times, FDA officials said “every medical device comes with a certain level of risk, whether it is a pair of crutches or a heart valve.” Devices no longer designated high risk are still reviewed, the statement said, and the agency may request additional information to ensure that devices coming to market are “reasonably safe and effective.”

How medical devices come to market has long been controversial. In 2011, an Institute of Medicine report called the FDA’s regulation system “flawed,” saying it does not adequately examine the safety and effectiveness of the devices. A 2011 study found that the vast majority of medical devices recalled between 2005 and 2009 because of life-threatening risks had reached the market without a rigorous premarket approval process. And some devices, though considered equivalent to earlier products, were in fact designed differently or made of different materials.

The Times said that although the FDA may never require proof that certain devices are safe and effective, manufacturers themselves may do the evaluation. Two companies that make external cardiac compressors have sponsored clinical trials to prove their devices are as safe as manual CPR, for example.

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